The FDA Curtain

First Steps

Lipper started by ironing out what he wanted his product to be: a tattoo with medication that would enter the skin on a time-release basis, over anywhere from eight hours to one week. He wanted the tattoo to have color-changing ability as well. Then he was off to meet with his patent attorney to see if any prior patents for similar ideas existed. The search didn't turn up anything, so Lipper was ready to start developing his idea.

He ran into several problems, though. First, he didn't know a chemist who could create a prototype. Second, he didn't know anyone who was familiar with submitting ideas to the FDA. And finally, most chemists and FDA consultants in the market prefer working with large companies that can offer big checks for services.

Lipper turned to his patent attorney for help, and his attorney referred him to consultants who recommended a recently retired chemist who was well-connected to the FDA. After meeting with Lipper, the chemist agreed to work on the project because he believed it was a great idea.

Unfortunately, inventors often don't realize what a valuable resource the right patent attorney can be-especially patent attorneys who specialize in a particular market. They have other clients and can frequently steer you to useful contacts. You can find a patent attorney by asking other entrepreneurs in the same field who their patent attorneys are, by checking for similar patents on the PTO Web site and finding out what attorneys handle them, and by checking with the American Intellectual Property Law Association (AIPLA) for attorneys who handle products similar to yours. Visit AIPLA's Web site for details.

You've Got Questions . . .
FDA regulations require manufacturers (also called sponsors) to submit INDs (investigational new drug applications) for approval. Because the process can be complicated, the FDA schedules pre-IND meetings to help sponsors figure out what clinical trials and testing are required and what to include in the IND submission. Your best bet at getting the help you need to set up an initial meeting is to contact one of the FDA's five regional offices, which are specifically created to help businesses:
Herman Janiger
Jamaica, New York
phone: (718) 340-7000, ext. 5618
fax: (718) 662-5434

Marie T. Falcone
phone: (215) 597-4390, ext. 4003
fax: (215) 597-5798

Barbara Ward-Groves
phone: (404) 253-0258
fax: (404) 253-1207

Brenda C. Baumert
phone: (214) 655-8100, ext. 133
fax: (214) 655-8130
e-mail: bbaumert@ora/

Mark S. Roh
Oakland, California
phone: (510) 637-3960, ext. 701
fax: (510) 637-3976

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This article was originally published in the May 2001 print edition of Entrepreneur with the headline: The FDA Curtain.

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